Waters, 176006049, GTxResolve 2000Å SEC Column, MaxPeak Premier 3 μm, 7.8x150 mm and DNA Vector Mixture Standard

Waters GTxResolve 2000Å SEC Columns, MaxPeak Premier 3µm are manufactured with low adsorption MaxPeak HPS hardware and novel bridged ethylene HO-PEO particles to support high recovery analyses of 800 to 2500Å diameter GTx drugs, such as plasmids, LNPs, and larger viral vectors. This column technology provides long column lifetimes, low secondary interactions, and improved MALS sensitivity. Facilitate the development of platform multiattribute SEC assays for plasmid integrity and LNP formulations analyses as well as improved detection of ejected transgenes and aggregates related to viral vectors. The Waters DNA Vector Mixture contains 25 µg of pBR322 dsDNA vector, 25 µg of Φ174 Virion ssDNA and 2 µg uracil (void marker). This standard can be used as a proficiency and system suitability test standard for chromatography separations, such as a size exclusion separation using a widepore 2000Å particle column.

The Waters GTxResolve 2000 Å size-exclusion chromatography package combines a MaxPeak Premier analytical column with a DNA Vector Mixture Standard for gene-therapy-related separation development and system suitability testing. The column has a 7.8 mm internal diameter, a 150 mm length and 3 µm packing with a nominal 2000 Å pore size. Low-adsorption MaxPeak surface technology is designed to reduce unwanted analyte–hardware interactions when evaluating large biomolecular assemblies, including plasmids and selected lipid nanoparticle or vector preparations. The accompanying standard comprises pBR322 double-stranded DNA vector, ΦX174 virion single-stranded DNA and a uracil void marker. Establish suitable SEC mobile-phase conditions and a detection strategy before method qualification, then assess recovery, peak shape and elution order. Avoid using denaturing or strongly interacting mobile phases that undermine the intended size-based separation. Confirm the installed system's pressure, tubing and detector configuration, particularly for SEC-MALS. The standard is included in this package and is not a second analytical column.